MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-19 for BIOGLUE SURGICAL ADHESIVE UNKNOWN manufactured by Cryolife, Inc. ? Kennesaw.
[139290820]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[139290821]
According to reports, surgeon commented adverse reaction possibly due to use of bioglue. A male, (b)(6) years old, copd, (b)(6), upper third lobectomy, right lung. Strong inflammatory reaction maintained in the suture area (in parenchyma), preventing sealing of the air leak. Sometime around 2017/2018. 3 to 5 cc. With rigid cannula. Aerial leak, reoperated at 19/21 days by minithoracotomy, the field is observed directly. The intervention took place at christmas 2017, surgical intervention took place after the holidays (about two weeks or so). Surgeon remembered "the tissue at the scarred edges of the distal area (on which he had applied bioglue), presented signs of inflammation, observed the edge of the mechanical suture, applied previously with a manual suture (polypropylene monofilament), to approximate the edges. Again used bioglue as sealant (about 3cc), after a few minutes of drying, proceeded to make a test sealing (vasalva), resulting satisfactory; after a few days of observation, patient was discharged from hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2019-00012 |
| MDR Report Key | 8434584 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-19 |
| Date of Report | 2019-03-21 |
| Date Facility Aware | 2019-03-13 |
| Date Mfgr Received | 2019-03-13 |
| Date Added to Maude | 2019-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROCHELLE MANEY |
| Manufacturer Street | 1655 ROBERTS BLVD |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOGLUE SURGICAL ADHESIVE |
| Generic Name | GLUE,SURGICAL,ARTERIES |
| Product Code | MUQ |
| Date Received | 2019-03-19 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. ? KENNESAW |
| Manufacturer Address | 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2019-03-19 |